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Job Description
Regulatory Affairs Director Opportunity
We are seeking a highly skilled Regulatory Affairs Director to join our team at Optum. As a key member of our regulatory team, you will play a critical role in ensuring compliance with local and international regulations, including FDA, EMA, and other relevant regulatory agencies.
Key Responsibilities:
- Develop and implement regulatory strategies for our new service line, ensuring adherence to all applicable regulatory requirements.
- Coordinate and manage the preparation, submission, and tracking of licensure applications, ensuring completeness, accuracy, and timeliness.
- Provide guidance and support to project teams regarding regulatory requirements and potential risks and mitigation strategies.
- Maintain an organized and up-to-date repository of all licensure-related documentation, including licenses, permits, certificates, and other relevant records.
- Stay informed about changes in regulatory requirements and guidelines related to licensure support and ensure timely implementation of any necessary updates or modifications.
Requirements:
- Proven experience in licensure support (or bachelor's equivalent) within the pharmaceutical or life sciences industry.
- Strong knowledge of regulatory requirements and guidelines related to licensure support, including FDA and EMA labeling guidelines.
- Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively.
- Attention to detail and accuracy in documentation and record-keeping.
- Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders.
What We Offer:
At Optum, we offer a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.